DIGITAL TENS DUAL CHANNEL

GUDID 04716770925806

DIGITAL TENS DUAL CHANNEL

BESMED HEALTH BUSINESS CORP.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04716770925806
• NIH Device Record Key: 623a6306-1df9-4ffa-8b9a-56cef6cd65c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIGITAL TENS DUAL CHANNEL
• Version Model Number: BE-92580
• Company DUNS: 658023775
• Company Name: BESMED HEALTH BUSINESS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04716770925806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031375

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-12-15

On-Brand Devices [DIGITAL TENS DUAL CHANNEL]

• 04716770926605: BE-92660
• 04716770925806: DIGITAL TENS DUAL CHANNEL
• 04716770005805: BE-580